CATHETER APPARATUSES HAVING MULTI-ELECTRODE ARRAYS FOR RENAL NEUROMODULATION AND ASSOCIATED SYSTEMS AND METHODS

• US 20120143293A1
• Filed: 10/25/2011
• Published: 06/07/2012
• Est. Priority Date: 10/25/2010
• Status: Active Grant

• Current Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Original Assignee: Medtronic Ardian Luxembourg SARL (Medtronic Plc)
• Inventors: Mauch, Kevin, Beetel, Robert, Chang, William, Goshgarian, Justin, Rivera, Leonila, Silver, Michele, Wu, Andrew, Zarins, Denise, Aboytes, Maria G., Alvarado, Mario, Shin, Sukyoung, Som, Sina, Sanchez-Cole, Juanita
• Granted Patent: US 8,956,352 B2
• Time in Patent Office: Days
• US Class Current: 607/99
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2018/00023 closed, i.e. without wound contact by the fluid
• CPC Class Codes: A61B 2018/00404 Blood vessels other than those in or around the heart
• CPC Class Codes: A61B 2018/00434 Neural system
• CPC Class Codes: A61B 2018/00505 Urinary tract
• CPC Class Codes: A61B 2018/00511 Kidney
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/1435 Spiral
• CPC Class Codes: A61B 2018/1467 using more than two electrodes on a single probe
• CPC Class Codes: A61M 25/0041 pre-formed, e.g. specially adapted to fit with the anatomy of body channels urethral catheters A61F2/04
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0133 Tip steering devices
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires

Abstract

Catheter apparatuses, systems, and methods for achieving renal neuromodulation by intravascular access are disclosed herein. One aspect of the present technology, for example, is directed to a treatment device having a multi-electrode array configured to be delivered to a renal blood vessel. The array is selectively transformable between a delivery or low-profile state (e.g., a generally straight shape) and a deployed state (e.g., a radially expanded, generally helical shape). The multi-electrode array is sized and shaped so that the electrodes or energy delivery elements contact an interior wall of the renal blood vessel when the array is in the deployed (e.g., helical) state. The electrodes or energy delivery elements are configured for direct and/or indirect application of thermal and/or electrical energy to heat or otherwise electrically modulate neural fibers that contribute to renal function or of vascular structures that feed or perfuse the neural fibers.

Claims

1. A catheter apparatus for treatment of a human patient via renal denervation, the catheter apparatus comprising:

a therapeutic assembly having a central axis and a distal portion and a proximal portion axially spaced along the central axis, the therapeutic assembly including—

a plurality of energy delivery elements including at least a first energy delivery element and a second energy delivery element; and

a shapeable region moveable between a delivery state and a deployed state, wherein the plurality of energy delivery elements are carried by the shapeable region;

a control member operably coupled to at least a portion of the therapeutic assembly and disposed along the central axis such that the first and the second energy delivery elements are axially and radially spaced from one another about the control member, and wherein—

proximal movement of the control member relative to the distal portion of the therapeutic assembly places the therapeutic assembly in the delivery state; and

distal movement of the control member relative to the distal portion of the therapeutic assembly places the therapeutic assembly in the deployed state.

2. The catheter apparatus of claim 1 wherein the control member comprises a tubular member defining a central lumen, and the central lumen is configured to receive a guide wire.

3. The catheter apparatus of claim 1, further comprising a shaft having a guide wire lumen at the distal portion, wherein the control member is slidably received in the guide wire lumen and configured to advance and retract relative to the theraputic assembly.

4. The catheter apparatus of claim 1 wherein the theraputic assembly comprises a pre-formed helical structure.

5. The catheter apparatus of claim 1 wherein the control member comprises a stylet.

6. A catheter apparatus, comprising:

an elongated tubular shaft defining at least one lumen;

a therapeutic assembly disposed distally of the elongated shaft, the therapeutic assembly defining a central axis and having a distal portion and a proximal portion axially spaced along the central axis, the therapeutic assembly including—

a plurality of energy delivery elements including at least a first energy delivery element and a second energy delivery element; and

a support member moveable between a delivery arrangement and a deployed arrangement;

a control member coupled to the distal portion of the therapeutic assembly and disposed along the central axis such that the first and the second energy delivery elements are axially and radially spaced from one another about the control member, wherein—

distal movement of the control member relative to the elongated shaft places the therapeutic assembly in a delivery arrangement; and

proximal movement of the control member relative to the elongated shaft places the therapeutic assembly in a deployed arrangement; and

a guide assembly coupled to the therapeutic assembly and disposed along the central axis of the therapeutic assembly, wherein the guide assembly includes a tubular member having an opening disposed at the proximal portion of the therapeutic assembly for insertion and removal of a guide wire.

7. The catheter apparatus of claim 6 wherein the therapeutic assembly comprises a plurality of spiral members disposed about the inner member.

8. The catheter apparatus of claim 6 wherein the delivery arrangement of the therapeutic assembly defines a delivery profile of about 0.085 inch (2.16 mm).

9. The catheter apparatus of claim 6 wherein a distal end of the elongated shaft further comprises a skived or oblique notch sized and shaped to nest with a proximal end of the control member.

10. The catheter apparatus of claim 6 wherein the elongated shaft comprises a first lumen and a second lumen, and wherein the control member is slidably disposed in the first lumen, and a plurality of energy delivery element leads are disposed in the second lumen.

11. A catheter apparatus for intravascular modulation of renal nerves, the catheter apparatus comprising:

an elongated shaft having a proximal portion and a distal portion, wherein the distal portion of the shaft is configured for intravascular delivery to a renal artery of a human patient;

a helical structure disposed at or proximate to the distal portion of the elongated shaft, wherein the helical structure is configured to vary between a low-profile configuration and a deployed configuration; and

at least two energy delivery elements associated with the helical structure, wherein the energy delivery elements are configured to thermally inhibit neural communication along the renal artery, and

wherein the two energy delivery elements are secured about the helical structure such that in the deployed configuration, the helical structure and the energy delivery elements define a delivery profile of 0.085 inch (2.16 mm) or less, and

wherein, in the deployed configuration, the energy delivery elements of the helical structure are configured to maintain stable contact with a wall of the renal artery.

12. The catheter apparatus of claim 11, further comprising a control member movable relative to the helical structure to alter the helical structure between the low-profile configuration and the deployed configuration.

13. The catheter apparatus of claim 11 wherein the control member defines a central lumen, and wherein the central lumen is configured to receive a guide wire to locate the helical structure at a target location within a renal artery of the patient.

14. The catheter apparatus of claim 11, further comprising a delivery sheath at least partially surrounding the helical structure in the low-profile configuration.

15. The catheter apparatus of claim 11 wherein the elongated shaft comprises a guide wire lumen, and wherein the catheter apparatus further comprises a guide wire positioned in the guide wire lumen and extending to a treatment site in the renal artery.

16. The catheter apparatus of claim 11 wherein the helical structure comprises a braided cable.

17. The catheter apparatus of claim 11 wherein the helical structure comprises a tubular support structure having a central lumen.

18. The catheter apparatus of claim 11 wherein the helical structure comprises an electrically conductive material and wherein the electrically conductive material comprises a portion of the energy delivery element.

19. The catheter apparatus of claim 18 wherein the electrically conductive material is covered only in part by an electrically insulating material.

20. A catheter apparatus, comprising:

an elongated shaft comprising an outer shaft and an inner shaft, wherein the elongated shaft has a proximal portion and a distal portion, and wherein the distal portion of the elongated shaft is configured for intravascular delivery to a renal artery of a human patient;

a treatment section at the distal portion of the elongated shaft, wherein the treatment section extends between a distal end of the outer shaft and a distal end of the inner shaft, and wherein a distal end of the treatment section is slidably coupled to the distal end of the inner shaft via a dual lumen sleeve;

a plurality of energy delivery elements carried by the treatment section; and

a pre-shaped section coupled to the treatment section, wherein the pre-shaped section is configured to impart a shape to the treatment section, thereby altering the treatment section from a straightened delivery configuration to a deployed configuration for placing the energy delivery elements in contact with tissue at a treatment site.

21. The catheter apparatus of claim 20 wherein the treatment section further includes an insulator disposed between the energy delivery elements and the pre-shaped section to electrically isolate the energy delivery elements from the pre-shaped section, and wherein the insulator is formed of a material that allows the thermal energy transfer between the energy delivery elements and the shape memory component.

22. The catheter apparatus of claim 20 wherein the insulator is formed from a thermoplastic material having ceramic filler mixed therein.

23. The catheter apparatus of claim 20 wherein:

the energy delivery elements are electrically connected to an energy source via at least one wire having a proximal end coupled to the energy source and a distal end coupled to the energy delivery element; and

the at least one wire is a bifilar wire that includes a first copper conductor, a second copper or nickel conductor, and insulation surrounding each of the first and second conductors to electrically isolate them from each other.

24. The catheter apparatus of claim 23 wherein the treatment section comprises a series of band electrodes.

25. The catheter apparatus of claim 23 wherein the deployed configuration of the -pre-shaped section comprises a helix.

26. The catheter apparatus of claim 20 wherein the pre-shaped section comprises nitinol.

27. The catheter apparatus of claim 26 wherein the pre-shaped section comprises a solid wire covered by a thin layer of insulative material.

28. The catheter apparatus of claim 20 wherein the pre-shaped section has a lumen therethrough sized to accommodate a guide wire.

29. The catheter apparatus of claim 20 wherein the pre-shaped section is polymeric.

30. The catheter apparatus of claim 20 wherein the pre-shaped section comprises a shape-memory material that is configured to undergo a shape transformation at a shape transformation temperature between about 40°

C. and about 45°

C.

31. The catheter apparatus of claim 20, further comprising an insulator coupled to the pre-shaped section, wherein the insulator comprises a tubular sheath having an insulator lumen.

32. The catheter apparatus of claim 31 wherein a proximal end of the insulator is affixed to an inner surface of the outer sheath and distal end of the insulator is disposed in the dual lumen sleeve.

33. The catheter apparatus of claim 20, further comprising a guide wire shaft within the dual lumen sleeve.

34. A catheter apparatus, comprising:

an elongated tubular shaft defining at least one lumen;

a therapeutic assembly disposed distally of the elongated shaft, the therapeutic assembly defining a central axis and having a distal portion and a proximal portion axially spaced along the central axis, the therapeutic assembly including—

a plurality of energy delivery elements including at least a first energy delivery element and a second energy delivery element; and

a support member moveable between a delivery arrangement and a deployed arrangement;

a tubular shaft member coupled to the distal portion of the therapeutic assembly and disposed along the central axis such that the first and the second energy delivery elements axial movement of the tubular shaft member relative to the elongated shaft places the therapeutic assembly in a one of a delivery arrangement and a deployed arrangement; and

a guide wire disposed within the tubular shaft member.

35. A catheter apparatus for treatment of a human patient via renal denervation, the catheter apparatus comprising:

an elongated tubular shaft;

a therapeutic assembly having a central axis and a distal portion and a proximal portion axially spaced along the central axis, the therapeutic assembly comprising—

a support structure selectively transformable between a delivery arrangement and a deployed arrangement

a plurality of energy delivery elements carried by the support structure; and

a control member slidably received in the shaft and operably coupled to a distal portion of the therapeutic assembly, wherein—

proximal movement of the control member places the therapeutic assembly in the deployed arrangement; and

distal movement of the control member places the therapeutic assembly in the delivery arrangement.

36. The catheter apparatus of claim 35 wherein the therapeutic assembly comprises six energy delivery elements.

37. The catheter apparatus of claim 35 wherein the elongated tubular shaft and the control member define a central lumen, and wherein the central lumen is configured to receive a guide wire to locate the therapeutic assembly at a target location within a renal artery of the patient.